CClinicalTrials.gg
CompletedNCT00746083Updated Aug 16, 2019

Challenge!, a Health Promotion/ Obesity Prevention Program for Teens

An interventional study of Challenge! in Overweight, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-16.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
235
Allocation
Randomized
Ages
11 Years to 16 Years
Sex
All
01

Study summary

The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier BMI-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.

Read the detailed description

Pediatric overweight is a major public health problem in the US, with the prevalence of overweight among children of all ages increasing dramatically over the past several decades. Interventions aimed at reducing the increased weight gain during adolescence have produced mixed results.

Challenge! is a randomized controlled trial for health promotion/ obesity prevention targeting low-income, urban, African American adolescents. Healthy adolescents were recruited from an urban medical center and from local middle schools. Weight status was not part of the inclusion criteria.

The intervention was home- and community-based and delivered one-on-one to each adolescent by a college-age "personal trainer". The intervention focused on goal-setting, consuming a healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and convenience foods), and increasing physical activity. We hypothesized that the teens enrolled in the intervention would have a healthier BMI-for-age z-score and a healthier body composition (body fat %) compared to those that did not receive the intervention over time. Additionally, we hypothesized that those enrolled in the intervention would consume healthier diets and have higher levels of physical activity compared to those that did not receive the intervention over time.

02

Conditions studied

  • Overweight

Keywords

  • pediatric
  • obesity
  • African American
  • adolescents
  • intervention
  • home-based
  • community-based
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 235 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 129 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ages 11-16, willing to participate in a randomized controlled trial for health promotion

Exclusion criteria

Exclusion Criteria:

  • Outside of age range
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
235 participants (actual)

Study arms

  • Experimental
    Intervention group

    Behavioral: Challenge!

  • No intervention
    Control group

Interventions

  • BehavioralChallenge!

    Each adolescent in the intervention group received 12 lessons administered in adolescent's home or community by a "personal trainer" (a college-aged mentor). The lessons focused on behavior change relating to diet and physical activity and was based on social cognitive theory. At the end of each lesson the adolescent set a behavior change goal for themselves. The adolescents were taught how to track their goals and they discussed thir ability/inability to meet their goals at each meeting with their personal trainer.

    Also known as: Obesity prevention, Goal setting, Diet, Physical activity

06

What researchers measure

Primary outcomes

  1. BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis)

    Time frame: 2 years

Secondary outcomes

  1. Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)

    Time frame: 2 years

07

Study locations

1 site
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
08

References and documents

Publications

  • Snitker S, Le KY, Hager E, Caballero B, Black MM. Association of physical activity and body composition with insulin sensitivity in a community sample of adolescents. Arch Pediatr Adolesc Med. 2007 Jul;161(7):677-83. doi: 10.1001/archpedi.161.7.677. PubMed 17606831 ↗
  • Mitola AL, Papas MA, Le K, Fusillo L, Black MM. Agreement with satisfaction in adolescent body size between female caregivers and teens from a low-income African-American community. J Pediatr Psychol. 2007 Jan-Feb;32(1):42-51. doi: 10.1093/jpepsy/jsl004. Epub 2006 Jun 8. PubMed 16762992 ↗
  • Devonshire AL, Hager ER, Black MM, Diener-West M, Tilton N, Snitker S. Elevated blood pressure in adolescent girls: correlation to body size and composition. BMC Public Health. 2016 Jan 26;16:78. doi: 10.1186/s12889-016-2717-6. PubMed 26812968 ↗
  • Black MM, Hager ER, Le K, Anliker J, Arteaga SS, Diclemente C, Gittelsohn J, Magder L, Papas M, Snitker S, Treuth MS, Wang Y. Challenge! Health promotion/obesity prevention mentorship model among urban, black adolescents. Pediatrics. 2010 Aug;126(2):280-8. doi: 10.1542/peds.2009-1832. Epub 2010 Jul 26. PubMed 20660556 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00746083
Lead sponsor
University of Maryland, Baltimore
Collaborators
Annie E. Casey Foundation, The Thomas Wilson Sanitarium for Children of Baltimore City, Johns Hopkins Bloomberg School of Public Health, University of Massachusetts, Worcester
Responsible party
Maureen Black (Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Sep 3, 2008
Start date
Apr 2001
Primary completion
Jul 2005
Completion
Jan 2007
Last update
Aug 16, 2019

Study contacts

Maureen M Black, PhD
principal investigator · University of Maryland School of Medicine, Department of Pediatrics, United States

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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